Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT01559168
Brief Summary:
The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.
Detailed Description:
Secondary objectives include the evaluation of the following:
* Change from baseline of POP-Q scoring at 6 weeks, 6 months and 12 months post procedure, including evolution of treated or non-treated posterior compartments.
* The proportion of patients with anatomical prolapse (C/D), but who are asymptomatic.
* Change from baseline of mean quality-of-life scores.
* Evaluation of mesh properties from procedure date through study period.
* Peri-operative and post-treatment pain score assessment comparing the various anesthesia regimes used (Visual Analog Scale).
* Assessment of patient subjective outcomes for overall treatment effects and satisfaction.
* Objective evaluation of mesh shrinkage by standardized ultrasound measurements.
Study:
NCT01559168
Study Brief:
Protocol Section:
NCT01559168